Electronic submissions are going global, and the FDA is leading the way.

If you understand the FDA's requirements, you can satisfy any regulator worldwide. This two-day interactive workshop will bring you fully up to speed.

President Obama signed the FDA Innovation and Safety Act that, beginning October 1, 2012, mandates electronic submissions for INDs, NDAs, BLAs, ANDAs, DMFs, and all CDRH pre- and postapproval submissions. Every day regulatory authorities across the globe are turning to electronic submissions as their new preferred format ... and the FDA is leading the way.

If you don't yet have your electronic submission process perfected, there's no time to lose.

Attend Preparing for the New Electronic Submission Mandate and you will:

Discover the top 10 reasons sponsors receive a refuse-to-file from the FDA on their eCTD submissions and steps you should take to avoid these conditions in your source documents and eCTD compilation process

Gain clarity on the acronyms and jargon of eCTD and electronic submissions

Effectively budget for all scenarios of eCTD production outsourcing, in-house publishing or a combination

Develop project plans for eCTD submissions

Understand why and how to start producing eCTD submissions at the IND phase

Compare the similarities and differences between the eCTD format and CDRH's Electronic Copy format.

Target skill requirements for MS Office and Adobe Acrobat that apply across all electronic submission standards.

Master the documentation requirements for electronic datasets for nonclinical and clinical studies and better communicate these requirements to colleagues early in the drug development cycle

Understand how to impact the deliverables from outside suppliers including contract writers, CROs and CMOs to assure your company is receiving submission-ready documents and datasets

Assure the output of your outsource vendor or in-house eCTD system is valid for FDA review

Learn about the eCTD pilot what it does, why you need it, how it works and how to make it work for you

Learn about the FDA's Electronic Submissions Gateway (ESG) and how to submit your eCTDs electronically, including unique requirements the ESG imposes on your eCTD publishing process

Create quality control checklists for documents and data to be included in your eCTD application

Develop a cost justification for outsourcing and know how to control your budget and avoid out-of-scope charges when outsourcing your eCTD

Develop a business case for purchasing an eCTD system and electronic document management system (EDMS) as part of your total solution for eCTD submissions

Analyze cost and timelines for selection, implementation and validation of eCTD publishing systems and understand who the vendors are and their products' distinguishing characteristics

Understand the interdependencies of submission life cycle and document management systems in combination with eCTD publishing systems and the importance of submission life cycle management

Participate in breakout sessions where you'll develop an eCTD strategy for your company

This workshop's expert instructor, Antoinette Azevedo, founded eâ'SubmissionsSolutions.com to advise all sizes of biotechnology and pharmaceutical companies on the use of technology to manage regulatory documents and publish electronic submissions.

She was director of West Coast Operations for Liquent from 1997 to 2000. She was principal consultant in the CSC Consulting life sciences practice as technical lead for regulatory submission publishing from 1994 to 1997, working with pharmaceutical clients both large and small in North America and Western Europe.

You Get Complete Presentation Slides & CD of Invaluable Documents

Plus, you'll walk away from this interactive workshop with presentation slides and a valuable CD you can put to use immediately that includes:

QC checklists for MS Word files and PDF files

MS Project plan for eCTD and study reports

Document inventory for eCTD RFI/RFP

Sample eCTD RFP and requirements matrix

ICH and FDA and global health authority guidances

List of EDMS vendors, including a matrix that cross-referencesintegration between eCTD and EDMS systems

MS Word template example for creating submission-ready PDF files

Software

Sample submissions for eCTD and CDRH Electronic Copy

White papers

And much, much more!

CONFERENCE DETAILSPreparing for the New Electronic Submission Mandates:Mastering the Tools and Strategies**Presented by FDAnews and e-SubmissionsSolutions.com**Dec. 6-7, 2012Raleigh, NC